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Marel

⚠️ Moderate Risk

FEI: 1000651829 • Reykjavik • ICELAND

FEI

FEI Number

1000651829

📍

Location

Reykjavik

🇮🇸

Country

ICELAND
🏢

Address

Hofdabakka 9, , Reykjavik, , Iceland

Moderate Risk

FDA Import Risk Assessment

35.2
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

2
Total Refusals
2
Unique Violations
3/4/2005
Latest Refusal
2/11/2004
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
18.9×10%
How is this score calculated?

Proprietary Algorithm

  • 40% Violation Severity — AI-assessed (1-10)
  • 30% Refusal Volume — Logarithmic scale
  • 20% Recency — Decays over 5 years
  • 10% Frequency — Refusals per year

© ImportRefusal.com Original Analysis

Violation Summary

1261×

FAILS STD

The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.

4761×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

Refusal History

DateProductViolationsDivision
3/4/2005
94I13INDUSTRIAL X-RAY SYSTEM (EXCEPT CABINET)
476NO REGISTR
Baltimore District Office (BLT-DO)
2/11/2004
94I17CABINET X-RAY SYSTEM
126FAILS STD
Atlanta District Office (ATL-DO)

Frequently Asked Questions

What is Marel's FDA import refusal history?

Marel (FEI: 1000651829) has 2 FDA import refusal record(s) in our database, spanning from 2/11/2004 to 3/4/2005.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Marel's FEI number is 1000651829.

What types of violations has Marel received?

Marel has been cited for 2 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about Marel come from?

All FDA import refusal data for Marel is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.